1. Field of the Invention
The present invention relates to a device for irrigation of externally debouching, natural or artificial body canals of animals or human beings, to a method of producing such a device, and to the use of such a device for performing an irrigation of externally debouching, natural or artificial body canals of animals or human beings. The device is especially suitable as a disposable xe2x80x9cready to usexe2x80x9d kit for trans-anal irrigation.
2. Description of the Prior Art
Continence can be defined as the ability to control defaecation, to be able to distinguish flatus from loose respectively formed faeces and to be able to maintain continence even during sleep without the use of external aids.
British studies have shown the prevalence of faecal incontinence in the adult population to be 0.5% approximately and the prevalence among women over 65 years of age to be 1.5% approximately. Around 80% of patients with spinal cord injury (SCI) and myelomeningocele as well as the analatresia patients are suffering from faecal incontinence.
The nerves and muscles of the colon, rectum and anus function together in a closely co-ordinating manner in order to maintain continence.
If some of these functions are out of order or do not work properly, e.g., if a person is suffering from some kind of defect in the control of the anorectum, this person will very possibly be incontinent.
The defects may be a result of a central damage, e.g., mental retardation or old age, or it may be a result of a spinal or peripheral damage, e.g., multiple sclerosis (MS), tumours or metastases, degenerative illness, cauda equina tumour (tumour in the end of the spinal cord-tail), peripheral disease of the nervous system (due to diabetes, MS) or obstetric sphincter rupture.
In addition to surgical treatment of incontinence, faecal incontinence, medication and regulating meal times and defaecation habits, enemas or irrigation are some of the treatments that have been practised for a long time.
Enemas or irrigation may also be used by completely healthy people if they for some reason want to avoid toilet visit for a longer period of time.
For this purpose several devices have been proposed during time. Besides devices especially for the use for performing irrigation for treatment of incontinence, other similar devices have been proposed for irrigation, i.e., products developed for the administration of barium sulphate enema or the like as part of a radiological examination.
U.S. Pat. No. 3,990,448 discloses an enema tip comprising an acorn portion at the end thereof, a distal staff portion connected to the acorn portion and a stop or locator portion connected to the distal staff. The locator portion includes a locator shoulder, which determine the proper degree of insertion of the tapered acorn portion of the enema tip. The enema tip is designed for introduction of a barium enema into the patient. The tip construction is said to provide a location feature itself and is thus said to make it unnecessary for the user to perform this function. Although the optimal diameter of the tip portion is claimed to be xe2x85x9e of an inch (xcx9c22 mm) which is to small if the device should be used for irrigation purposes. A simple enlargement of the device would not solve the problem as the pressure from a larger tip of that same material would tend to stress the muscles and the fragile wall of the rectum.
Another product is disclosed in U.S. Pat. No. 3,766,920. This product comprising a smooth, flexible enema tip having an inflatable balloon mounted on the stem behind the exit port from the tip. A limited volume, flexible, hand distendable air resorvoir is connected to the balloon like retention ring so that the operator compression of the reservoir will inflate the ring. As it appears from the description, this device is expected to be operated by a physician or his assistant. There is no indication whatsoever that the user could use this device without help.
U.S. Pat. No. 3,459,175 discloses a device for giving enemata including an inflatable balloon received on a pipe having an undulating outer shape. An additional balloon may be used on the pipe at a location spaced longitudinally of the first balloon. An abutment element may be provided which is mountable on said undulations and is positionable against the patient""s anus for blocking flow of fluid out of the patient""s bowel. According to an illustrated embodiment, the abutment element is elliptical so that it better fits the space between the buttocks when in use. This device is further provided with means for placing of air and barium into the colon without blowing barium into the colon. According to the description, this device is expected to be used by a nurse or other similar person.
The product disclosed in EP 109 897 A1 is a similar device with a fixation device in the form of a double balloon. One balloon is situated on the internal side of the sphincter and the other is situated on the external side of the sphincter. In this way the sphincter is subjected to pressure from both sides. Again the balloons need to be operated during and after insertion.
Further, GB 2 224 212 A discloses a rather complex rectal insertion device and control valve means therefor. The speculum in the colonic lavage apparatus comprises an elongated tubular body having a tapered leading end provided with a pair of diametrically opposed apertures. The major length of the body tapers rearwardly from the leading end into a trailing end which is coupled to a liquid delivery line from a source of liquid under pressure. If the speculum is to be held the anal canal of the patient, it may be provided with an inflatable cuff. As it appears from the description, this apparatus is a large and complex unit that need to be operated by assistant personnel.
Common disadvantages of the devices described above are that the use of a balloon as fixation member may cause a number of problems. Firstly, there is a risk that a balloon may be overfilled which may result in a rupture, that may cause damage of the fragile wall of the rectum, leakage of the liquid filled content of the colon sigmoideum and rectum and stress of the patient. Secondly, the balloon may leak which will let the air or the content of the balloon leak out. The result of this is that the device suddenly will fall out of the rectum followed by an often unpleasant leakage. As the users of these apparatus often have no sensory function in the rectum they will not register if the device is falling out. Thirdly, the balloons used in these devices are often made from latex. This may cause problems for patients and others suffering from latex allergy. Moreover, specialist have experienced that using a balloon as fixation member is acceptable for use when performing irrigation on children, because their rectum is narrower and not yet damaged from many years suffering from constipation as in many SCI adults. On the contrary, when the irrigation is carried out on adults there is a tendency that the balloon is not a very effective fixation member. When filling the balloon with more air in order to overcome the fixation problem, the balloon expands in both radial and axial direction. When expanding in axial direction the balloon may cover the eyes of the catheter, thus stopping the flow. When having to perform irrigation on small children a further problem arises because the devices commercially available today are rather large, they therefore seem rather scary both for the small children and for their parents. The existing products do not appear pleasant due to their size and colour.
All the above mentioned products have the further disadvantage that they do only disclose embodiments where the fixation member is placed very close to the sphincter and where the eyes of the catheter are positioned in rectum. Still further, the mentioned products are too expensive to use as disposable products. According to specialists these products are used several times for the same patient, while being cleaned in-between, this cleaning also being time consuming. Despite the cleaning in-between, the person skilled in the art will understand that there is a larger risk of contaminating the environment during storage of the product inbetween each use, compared to the use of a disposable product.
Finally, the devices for irrigation are often large and complex apparatuses, that are too expensive for the user to have at home and often need to be operated by an assistant.
Therefore, the above mentioned products do not fulfill the requirements of the users of irrigation devices.
The rectum is a very delicate part of the human body and it is required that it is protected from abrasion, perforation, infection as well as excessive pressure. Accordingly, any device which is intended for rectal insertion should not have any tendency to abrase or perforate the rectal wall even if coming into contact with the wall during insertion and must especially not have any sharp edges.
In order to ensure a high fulfillment of the users"" needs, it is further of utmost importance that the device for irrigation is very easy and safe to use. In other words, the device should be very simple to apply, the appearance of the device should not be scary to the user, it should not slip out during use, it should never leak, it should be secure against leakage, easy to get rid of after use, e.g., be disposable in the conventional systems in order to avoid cleaning, and it should be possible to position the eyes of the catheter based on the need, not only in rectum but also in colon sigmoideum and colon descendens.
The device for irrigation according to the present invention offers all these above mentioned features and advantages.
The object of the invention is to provide an irrigation device that will overcome all the disadvantages connected to the known products and render an irrigation simple and easy to perform. There is a high need for a device that solves the problems of the fixation member, provides for security against leakage problems, and, at the same time, can be used by both children and adults, without being scary in its appearance. A further object of the invention is to provide a disposable device in order to overcome infection problems and being time saving. Finally, the device should be easy to apply in order to avoid the need for an assistant. In other words the irrigation device according to the present invention will give the user a higher quality of life.